TEVA-ESCITALOPRAM TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

N06AB10

DCI (Dénomination commune internationale):

ESCITALOPRAM

Dosage:

15MG

forme pharmaceutique:

TABLET

Composition:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 15MG

Mode d'administration:

ORAL

Unités en paquet:

30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0150435003; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2015-10-16

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
TEVA-ESCITALOPRAM
(escitalopram oxalate)
Tablets 5 mg, 10 mg, 15 mg and 20 mg escitalopram (as escitalopram
oxalate)
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No. 119039, 138252
Date of Preparation:
September 23, 2010
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.................................................. 3
SUMMARY PRODUCT INFORMATION
................................................................. 3
INDICATIONS AND CLINICAL
USE.......................................................................
3
CONTRAINDICATIONS
............................................................................................
4
WARNINGS AND
PRECAUTIONS...........................................................................
4
ADVERSE
REACTIONS...........................................................................................
10
DRUG INTERACTIONS
...........................................................................................
20
DOSAGE AND
ADMINISTRATION.......................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 29
STORAGE AND
STABILITY...................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 31
PART II: SCIENTIFIC INFORMATION
........................................................................
32
PHARMACEUTICAL
INFORMATION...................................................................
32
CLINICAL
TRIALS...................................................................................................
34
DETAILED
PHARMACOLOGY..............................................................................
35
TOXICOLOGY
..................................................................